FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ENDO I/A PROBE

K Number: K924149 · Decision Jan 26, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
10
Review Days
161

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Basic Information

Device Name
ENDO I/A PROBE
K Number
K924149
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Snowden-Pencer
Date Received
August 18, 1992
Decision Date
January 26, 1993
Product Code
GCJ
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GCJ Laparoscope, General & Plastic Surgery

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.

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Other Clearances by Snowden-Pencer

K Number Device Name
K960400 DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
K930666 REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY
K930667 REUSABLE LAPAROSCOPIC INSTRUMENTS
K924148 DIAMOND-SHARP(R) TROCARS
K920985 SNOWDEN-PENCER IRRIGATION PUMP
K920986 SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
K913979 ENDO I/A Y SET
K913835 SNOWDEN-PENCER INSUFFLATOR TUBING SET
K861372 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY